Recall Z-2629-2017— Olympus Corporation of the Americas

Name: FDA recall Z-2629-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-19

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2017-04-19, terminated 2018-10-01. It names one FDA 510(k) clearance: K790071. Product: High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.. Reason: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2017-04-19
Terminated: 2018-10-01
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K790071 — ENDOSCOPE AND ACCESSORIESOlympus Corp.·cleared 1979-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

Reason for recall

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.